(MASS TORT NEXUS MEDIA) Plaintiffs have asked U.S. District Court Judge Ed Kinkeade, Northern District of Texas, who’s hearing thousands of hip implant lawsuits in the DePuy Orthopaedics’ Pinnacle Hip MDL 2244, to remand their cases to the original court of filing for individual trial dates.

According to the February 5th motion filed with the U.S. District Court, plaintiffs request the Court begin an “orderly and efficient staggered remand process,” where both plaintiffs and defense would select 10 cases each for remand to federal courts in California, New York and Texas, for a total of 60 cases being set for trial starting in 2019.

There were further requests that the Court begin not only the remand process, but start phased MDL discovery as well in peripherally related cases alleging RICO, qui tam and other non-personal injuries as part of the metal-on-poly hip revision lawsuits currently pending in the multidistrict litigation.

DePuy Pinnacle Implants and Metallosis

DePuy Orthopaedics, a subsidiary of Johnson & Johnson, have been named in more than 9,500 hip replacement lawsuits involving the metal-on-metal Pinnacle hip system, which utilizes the Ultamet liner, pending in the multidistrict litigation (see DEPUY MDL 2244 Pinnacle Hip Implant Briefcase) currently underway in the Northern District of Texas.

Plaintiffs allege that the metal-on-metal design within the Ultamet liner configuration can cause dangerous amounts of toxic metal debris to be released into the joint surround the hip, and into the blood stream resulting in metallosis, causing adverse local tissue reactions, pseudotumor formation, and other complications that necessitate the need for revision surgery to replace the DePuy hip implant components.

DePuy/J&J Loses Bellwether Trials

So far, the Pinnacle hip MDL 2244 litigation has convened four bellwether trials related to the metal-on-metal implants with the trial in October 2014, ending with a verdict for DePuy and Johnson & Johnson, which to date, is the only defense win in this litigation.

In the second trial, plaintiffs were awarded a verdict of $500 million in March 2016, however, Judge Kinkeade ultimately reduced the award to $151 million, based on Texas statutes that limit punitive damages. The third bellwether trial ending in December 2016, resulted in a massive billion dollar verdict, when six Pinnacle recipients who were residents of California were awarded more than $1 billion, with 90 percent of the verdict being punitive in nature, meant to send a clear message to the defendants. California does not have a limit on punitive damages, but the judge reduced the award to $543 million, based on the US Supreme Court ruling limiting excessive punitive damages. The most recent trial resulted in the plaintiff being awarded $247 million in November 2017.

J&J Wants To Avoid More Massive Verdicts

J&J are simply using every legal tool available to them, in an attempt to avoid another massive jury verdict like the one in the December 2016 Pinnacle Hip trial, where California plaintiffs were awarded $1 billion in punitive damages, which the court subsequently reduced to $500 million on appeal. DePuy and J&J want to restrict plaintiffs in any way they can, as J&J is facing massive verdicts in other ongoing federal and state court cases related to its various medical device and pharmaceutical product lines.

DePuy Metal-on-Metal Hip Implant Issues

In January 2013, the U.S. Food & Drug Administration warned that metal-on-metal hip replacements were associated with higher rates of early failure compared to those constructed from other materials. Last year, the FDA finalized a new regulation requiring the manufacturers of two types of metal-on-metal hips to submit a premarket approval (PMA) application if they wanted to continue marketing their current devices and/or market a new implant.

In August 2010, DePuy Orthopaedics announced a recall of its ASR metal-on-metal hip replacement system, after data indicated the hips were associated with a higher-than-expected rate of premature failure. Plaintiffs who have filed Pinnacle hip lawsuits question why the company has not taken similar action in regards to the Pinnacle/Ultamet liner combination.

In May 2013, DePuy Orthopaedics did announce that it would phase out metal-on-metal hip implants, including the Pinnacle hip system. The New York Times stated that the company cited slowing sales, as well as the FDA’s changing regulatory stance on all-metal hip implants, as factors in its decision.

Artificial hips are designed to last for 15 years in the best of situations, often that is not the case with many implants failing after just 10 years, and in the case of design defects such as those alleged in Pinnacle devices and many other hip implants, onset of metallosis and other adverse conditions resulting, as well as the ever present implant mechanical breakdown, which cause life altering health problems for patients.

FDA Issues Pinnacle Warning

The U.S. Food & Drug Administration issued a warning in January 2013, stating that patients receiving metal-on-metal hip replacements were more likely to experience premature device failure compared to those who received other types of implants.

In November 2013, DePuy Orthopaedics announced a $2.5 billion settlement in the DePuy ASR Hip Impant MDL2197 ( MDL 2197 DePuy Orthopaedics, Inc. ASR Hip Implant Briefcase), related to the ASR line of metal-on-metal hip implant components. DePuy ended sales of the all-metal Pinnacle hip system that same year, purportedly due to “low clinician use”. However, the company has so far declined to settle the Pinnacle hip litigation.

J&J Facing Many Legal Hurdles

Johnson & Johnson has been hit with numerous large jury verdicts across all areas of the J&J pharmaceutical and medical device operations, with plaintiff trial verdicts Risperdal, Ethicon TVM, Talcum Powder, Xarelto and other products, where recent combined trial verdicts have easily exceeded an additional $200 million. J&J and it’s subsidiaries are now facing more than 100 thousand lawsuits over it’s drug and medical device product lines, in both federal and state courts across the country. To complicate matters further for J&J, the recently started Opiate Prescription MDL 2804 (MDL 2804 Re: NATIONAL PRESCRIPTION OPIATE LITIGATION MDL 2804 Briefcase) names Johnson & Johnson as a defendant in suits filed by more than 400 cities, counties and states across the country.

They Have Opioid MDL Issues Too

Perhaps J&J should look at settling some of the cases they’ve defended so aggressively over the last 5 years, such as the Pinnacle MDL 2244 to prepare for the Opioid Crisis litigation, which is now looking to displace Tobacco Litigation as far as size and scope as well as the massive multi-billion dollar settlements and years of ongoing litigation that came from lawsuits filed initially by governmental entities.

Chief Justice Judge Harz issued an initial case management order on May 22. The first trial conference is set for June 21. The multicounty litigation was sought by 25 plaintiffs.

Motion follows recall

The Stryker LFIT was voluntarily recalled in August by Howmedica Osteonics Inc. when some taper locks failed. Plaintiffs allege that the part can fret and corrode, releasing metal particles and posing a risk of metallosis, necrosis, osteolysis and higher levels of cobalt and chromium in the bloodstream.

Howmedica opposed consolidation, saying existing cases are being effectively coordinated by Judge Harz. It suggested that if cases are consolidated, they be limited to cases involving the recalled LFIT V40 femoral heads that show taper lock failure.

The motion was filed by plaintiff attorney Ellen Relkin of Weitz & Luxenberg in New York.

US District Judge Indira Talwani in Boston will oversee a total of 33 cases from 17 district courts, with at least eight groups competing plaintiffs’ counsel involved, in In re: Stryker LFIT V40 Femoral Head Products Liability Litigation. Defendant HowmedicaOsteonics Corp. of Mahwah, NJ, unsuccessfully opposed centralization and wanted the cases heard in New Jersey or New York federal court.

42,519 defective hips

Howmedica recalled 42,519 of the defective hips on August 29, 2016. The company also issued a letter to orthopedic surgeons advising them of a “higher than expected” incidence of taper lock failure for certain sizes of its LFIT Anatomic CoCr V40 Femoral Heads.

Potential hazards listed in the recall notice included excessive metal debris, disassociation of the head from the stem/failure, trunnion fracture, and corrosion at the femoral head and stem junction.

Simultaneously, the Canadian public health agency issued a recall about the Stryker LFIT V40 and the Australian Government Department of Health published a Hazard Alert about the same devices.

The plaintiffs’ claims focus on the performance of the LFIT V40 cobalt-chromium device, in particular the alleged propensity of the device to cause corrosion at the taper junction when paired with femoral stems made from different alloys (such as Howmedica’s proprietary TMZF, which is an alloy of titanium, molybdenum, zirconium and iron). This corrosion allegedly leads to failure of the implant or other serious health consequences and necessitates surgery to remove and replace the implants.

In addition to the specific causes of the failure of each plaintiff’s device, the cases have common issues about the development, manufacture, testing, regulatory history, promotion, and labeling of the LFIT V40 cobalt-chromium femoral head. “We note, though, that the transferee judge might find it useful, for example, to establish different tracks for the different femoral stems that can be mated with the LFIT device,” the JPMDL said.

New Jersey plaintiffs

A different group of 25 plaintiffs is requesting that the New Jersey state courts create a multi-county litigation docket for the same device.

The New Jersey motion was filed Jan. 26 by attorney Ellen Relkin of Weitz & Luxenberg in New York. She estimates that more than 85 cases over the LFIT V40 Hip have been filed before Judge Rachelle Harz in Bergen County, NJ.

The New Jersey motion was filed Jan. 26 by attorney Ellen Relkin of Weitz & Luxenberg in New York. She estimates that more than 85 cases over the LFIT V40 Hip have been filed before Judge Rachelle Harz in Bergen County, NJ.

The federal MDL motion was filed Jan. 13 by attorney Walter Kelley of Kelley Bernheim & Dolinsky LLC in Plymouth, MA, requesting MDL No. 2768 be created in federal court in Massachusetts. The Judicial Panel on Multidistrict Litigation (JPMDL) will hear this motion on March 30 in Phoenix, AZ.

Defective hips

Defendant Stryker Howmedica Osteonics Corp. of Mahwah, NJ, recalled 42,519 of the defective hips on August 29, 2016. The company also issued a letter to orthopedic surgeons advising them of a “higher than expected” incidence of taper lock failure for certain sizes of its LFIT Anatomic CoCr V40 Femoral Heads.

Simultaneously, the Canadian public health agency issued a recall about the Stryker LFIT V40 and the Australian Government Department of Health published a Hazard Alert about the same devices.

The LFIT femoral head has been marketed fo ruse with a variety of femoral stems. Some medical literature says the problem arises when stems made of titanium or TMZF titanium alloy are combined with cobalt-chromium alloy femoral head and taper devices.

The problem involves fretting and corrosion in the junction where the femoral head connects to the femoral stem. Corrosion at this junction has led to the systematic release of metal particles into the surrounding tissue and bone, putting patients are risk of toxic metallosis, tissue death, bone death and elevated levels of cobalt and chromium in the blood.

Furthermore, excessive corrosion at the head-neck junction causes the femoral head to break off the from neck, become loose in the body, and depart from the acetabular cup where it is supported to move.

Revision surgery

Adverse events include loss of mobility pain, inflammation, adverse local tissue reaction, disassociation of the femoral head, dislocation, joint instability, broken bones and the need for revision surgery. Many of the New Jersey cases involve patients who have needed revision surgery.

All the cases allege design defect, failure to warn, breach of warranty and manufacturing defect.

Judge Harz is presiding over the LFIT litigation, as well as the Stryker Rejuvenate and ABG II litigation, which involves similar issues. “It is both logical and fair to the litigants for these cases to remain in Bergen County before Judge Harz,” attorney Relkin argues. She speculates that if a federal MDL were created in New Jersey, then “seamless coordination could occur between the federal MDL and state MCL litigation.”

The US Judicial Panel on Multidistrict Litigation (JPMDL) will hear argument on March 30 on whether to create new multi-district litigation docket (MDL) No. 2776 for Farxiga and Xigudo diabetes medicines.

Oral argument is scheduled starting in the morning at the US Courthouse in Phoenix, Arizona. In addition, oral arguments will be held to create the following MDLs:

Ketoacidosis and kidney failure

Plaintiff’s attorney Holly Dolejsi of Robins Kaplan L.L.P. in Minneapolis moved to transfer currently filed Faxiga and Xigduo cases to either the Southern District of New York before Judge Lorna G. Schofield, the Eastern District of Pennsylvania before Judge Mitchell Goldberg, or the Southern District of Illinois before Judge Nancy J. Rosenstengel, who all have Farxiga cases assigned to them.

The motion involves 18 pending cases in 6 district courts, with 13 of the 18 filed in New York. The Defendants The Defendants in these cases are Bristol-Myers Squibb Co., AstraZeneca Pharmaceuticals LP, AstraZeneca LP, AstraZeneca AB, and AstraZeneca PLC.

As a result of ingesting Farxiga, the plaintiffs have suffered sudden onset of life-threatening diabetic ketoacidosis (often in the setting of normal blood glucose levels), and/or acute renal failure, and/or pyelonephritis (kidney infection) and/or urosepsis and continue to suffer from the sequelae of these injuries. Farxiga (dapagliflozin) is a pharmaceutical drug used to treat Type 2 Diabetes. All of these injuries were the subject of recent FDA safety advisories. On January 8, 2014, the FDA approved Farxiga for use in

On January 8, 2014, the FDA approved Farxiga for use in treatment of type 2 diabetics.2 Farxiga is a part of the gliflozin drug class. The gliflozin class is referred to generally as SGLT2 (short for “Sodium Glucose Cotransporter 2”) inhibitors. Xigduo XR was (dapagliflozin combined with metformin) designed and made by the same defendants as Farxiga, and is an extension of the Farxiga product line. Xigduo XR was approved shortly after Farxiga, on October 29, 2014.

FDA safety warning

On December 4, 2015 the FDA issued a safety communication disclosing they had found 73 adverse events reported between March 2013 and May 2015 that required hospitalization due to ketoacidosis-related to SGLT2 inhibitors. The FDA noted adverse event reports “include only reports submitted to FDA, so there are likely additional cases about which we are unaware.”

The same safety communication also warned of “life-threatening blood infections (urosepsis) and kidney infections (pyelonephritis). In light of the data disclosed in the December 4, 2015 safety communication, the FDA changed the label for Farxiga and Xigduo XR to include a warning “about the risks of too much acid in the blood” and urged patients taking SGLT2 inhibitors to stop taking the drug and seek immediate medical attention if they have any symptoms of ketoacidosis. The FDA also required a label change to warn of urosepsis and pyelonephritis. On June 14, 2016, the FDA issued a safety announcement which advised that the existing warning about the risk of acute kidney injury on the Farxiga and Xigduo labels would be strengthened.

While a cross-motion to include Farxiga cases with Invokana MDL No. 2750 was raised, considered and ultimately denied by the Panel following the hearing in Charlotte, North Carolina, that request was opposed by both the Invokana Plaintiffs’ counsel and Defendants who claimed that the litigations were sufficiently different such that a joint SGLT2 MDL was improvident.

A total of 100 lawsuits have been filed in the MDL since the courts created it in December.

A Massachusetts hip replacement patient has requested that the Judicial Panel on Multidistrict Litigation (JPMDL) consolidate litigation against Stryker Orthopaedics over its defective LFIT V40 Anatomic Femoral Head devices, of which more than 100,000 units have been implanted into patients.

The new wave of litigation arises after Stryker Corporation issued an urgent medical device recall on August 29, 2016 related to the Stryker LFIT Anatomic CoCr V40 Femoral Head commonly used with the Stryker Accolade Hip replacement system as well as other models and brands of hip replacement products.

At the moment, six product liability actions over the LFIT device are pending in three jurisdictions, prosecuted by at least 10 different law firms. Plaintiff attorney Walter Kelley of Kelley Bernheim & Dolinsky LLC in Plymouth, MA, proposed that new MDL. No 2768 be located in federal court in Massachusetts before Judge Joseph L. Tauro, Judge Patti B. Saris, Judge Richard Saylor or Judge Indira Talwani.

The JPMDL has created MDLs in the court in Boston for litigation over GranuFlo/NaturaLyte, Zofran, Nexium, Neurontin, Celexa and Lexapro.

The prosthetic hip used in a total hip arthroplasty, more commonly known as total hip replacement, generally consists of several components – a femoral stem, a femoral head or ball, and an acetabular cup with liner. The Stryker LFIT V 40 Anatomic Femoral Head represents one part of a hip prosthesis and can be used across many hip replacement femoral hip stems manufactured and marketed by Stryker.

During hip replacement surgery, the femoral head is impacted onto the taper, in this case a V 40 taper, where it is supposed to lock in place. The failure of that taper lock causes excessive movement between the femoral head and the stem and ultimately leads to product failure.

On August 29, 2016, Stryker sent an “Urgent Medical Device Recall Notification” letter to surgeons that implanted or reported problems with certain Stryker LFIT V40 femoral heads manufactured prior to 2011. The letter explained that Stryker had received a higher than expected number of complaints involving taper lock failure of the recalled femoral heads.

In the letter, Stryker outlined the failure of the Stryker LFIT V40 femoral head and enumerated the reported problems associated with the device:

Dislocation of the femoral head from the hip stem

Hip stem fractures

Excessive metallic corrosion leading to cobalt and/ or chromium poisoning

Insufficient range of motion

Loss of implant/bone fixation strength

Excessive wear debris

Noise

Simultaneously, the Canadian public health agency issued a recall concerning the Stryker LFIT V40 and the Australian Government Department of Health published a Hazard Alert regarding the same devices.

The plaintiffs contend that Stryker knew for years that the LFIT V 40 femoral heads were defective and dangerous but instead chose to downplay the risk of using such device and failed to properly warn the hundreds of physicians implanting these devices

“In order for this Court, the cooperating New Jersey Multicounty Litigation (Master Docket No. BER-L-936-13), and any other cooperating courts to manage this litigation, as well as to assist the parties to effectuate the provisions of the private Settlement Agreement, it is necessary to continue to identify and update all remaining, unresolved filed and unfiled claims,” the judge said.

No dollar value was placed on the expanded settlement. Stryker said it expects most payments to be made by the end of 2017. About 20,000 people were implanted in the US with the Rejuvenate and ABG II hip replacement.

$1 billion settlement

Stryker recalled the Rejuvenate and ABGII hips in 2012. Plaintiffs allege that the metal-on-metal design of the hip joint components caused premature failure and resulted in metal debris causing pain, infection, tissue and bone death and difficult revision surgery.

The parties reached a $1 billion settlement in 2014. Eligible claimants will receive a base award of $300,000 for each revised hip. Unrepresented claimants are eligible for 71% of the base award, or $213,000. Reductions will be made for obesity, smoking and age, according to the settlement. Settlements may be increased up to $550,000 under an enhanced benefit program, for re-revision surgery, related additional surgery, dislocation of the femoral head of the hip, infections, inability to lift the front part of the foot, and pulmonary embolism or deep vein thrombosis during hospitalization.

Also, a second wave of plaintiffs for hip implant cases is emerging for injuries related to the LVIT v40 Femoral Head component recall. Stryker issued an urgent medical device recall on August 29, 2016 related to the Stryker LFIT Anatomic CoCr V40 Femoral Head commonly used with the Stryker Accolade Hip replacement system as well as other models and brands of hip replacement products.

$300,000 base settlement

Eligible claimants will receive a base award of $300,000 for each revised hip. Unrepresented claimants are eligible for 71% of the base award, or $213,000. Reductions will be made for obesity, smoking and age, according to the settlement. Settlements may be increased up to $550,000 under an enhanced benefit program, for re-revision surgery, related additional surgery, dislocation of the femoral head of the hip, infections, inability to lift the front part of the foot, and pulmonary embolism or deep vein thrombosis during hospitalization,

The MDL Plaintiffs’ committee, chaired by Peter J. Flowers of Meyers & Flowers of Chicago, reached a new settlement agreement in ongoing litigation against Stryker and Howmedica over the defective Stryker Modular Rejuvenate and ABG II Femoral Hip Implants. This new settlement encompasses patients who had the hip replacement system implanted and then removed after November 2014.

About 20,000 people were implanted in the US with the Rejuvenate and ABG II hip replacement. The settlement, much like the historic, unlimited compensation fund of more than $1 billion in restitution established in late 2014, is once again an unlimited fund for this new set of plaintiffs injured by these metal-on-metal hip replacement devices.

The global settlement includes plaintiffs from across the U.S. who underwent painful revision surgeries since the fall of 2014 to remove the defective devices regardless of if they filed a case in state or federal court. Settlement payments are expected to be distributed starting in 2017.

“This settlement is the latest chapter in the ongoing litigation against Stryker and Howmedica for the extensive, at-times crippling injuries of our clients, many of whom have experienced life-altering pain and disabilities due to these hip devices,” said Flowers. “Our continuing and tireless negotiations bring a degree of relief to these clients as well as hope to future victims of defective devices.”

Victims step forward in 2010

Flowers has spent decades litigating cases against Stryker and similar device manufacturers for their defective medical products. In 2010, he began to hear from victims of hip replacement injuries that echoed past metal-on-metal friction cases he dealt with in the Depuy Orthopedics of Johnson & Johnson recall lawsuits.

Stryker issued recalls for its Modular Rejuvenate and ABG II Femoral Hip Implants in July 2012 when he was already representing many clients who had been injured by these devices, even while the company continued to sell them.

The Stryker hip replacement devices had four components: the femoral stem, modular neck, ball and an acetabular cup. Once implanted, the metal components began to wear causing friction and metal shards to release toxins into the bloodstream.

During a hip replacement, the device stem is implanted in the femur bone. When the device fails or needs to be removed, the femur bone often has to be fractured, resulting in mobility issues that can last for six to eight months as well as painful side effects and extensive periods of rehabilitation.

“The ripple effect that has been seen year after year from these defective hip replacement devices is truly outrageous,” said Flowers. “When medical device makers put profit before patient safety, we all suffer. There are devastating consequences to the victim, their family, and community as well as the overall economy and the government, which is why protecting these injured parties is so essential.”

Stryker Corporation, notorious for its defective hip implants, must also pay a $7.6 million product liability settlement for its artificial knee joint called the Duracon Unicompartmental Knee (or “Uni-Knee”) according to the Sixth US Circuit Court of Appeals.

Also, a second wave of plaintiffs for hip implant cases is emerging for injuries related to the LVIT v40 Femoral Head component recall. Stryker issued an urgent medical device recall on August 29, 2016 related to the Stryker LFIT Anatomic CoCr V40 Femoral Head commonly used with the Stryker Accolade Hip replacement system as well as other models and brands of hip replacement products.

Defective knee replacements

There are 719,000 total knee replacements and 332,000 hip replacements performed annually in the U.S. (data from the Centers for Disease Control and Prevention (CDC). This number will grow exponentially with a more active and aging population.)

More than 7 million people in the U.S. have had a knee or hip replacement surgery

Hip and knee devices account for more than 85% of the joint reconstruction and replacement market

Joint registries demonstrate up to a 50% reduction in revision rates after registry initiation and identification of best practices

In the late 1990s, Stryker purchased a subsidiary of Pfizer, Inc. that made and sold the Duracon Unicompartmental Knee, which turned out to be defective. They were sterilized using gamma rays, which caused ultra-high molecular-weight polyethylene in the artificial knees to degrade and, if implanted past their five-year shelf life, potentially fail. Due to an inventory oversight, a number of expired Uni-Knees were sold to hospitals and implanted in patients.

Two policies, effective during the year 2000, were relevant: a “commercial umbrella” policy, issued by XL, and an “excess liability” policy, issued by TIG. The umbrella policy covered any “batch” of losses that Stryker became “legally obligated to pay by reason of liability imposed by law or assumed by the [i]nsured . . . because of [b]odily [i]njury.” That policy was limited to $15 million, after a $2 million self-insured retention.

The TIG excess liability policy kicked in after the umbrella policy was fully “exhausted,” and extended to Stryker’s “ultimate net loss . . . in excess of all underlying insurance” up to $25 million.

XL covered Stryker’s losses, but did so in non-chronological order: XL paid out the larger Pfizer judgment first, exhausted the limits of its coverage, and left Stryker’s individual product-liability claims on the table.

No written consent

Stryker sued TIG in the Western District of Michigan in 2013, seeking to recover the remaining $7.6 million paid to settle its direct product-liability claims. TIG disputed its coverage obligation, raising a defense that was “unique to [its] policy.” Stryker, 681 F.3d at 825 & n.4. In TIG’s view, the direct Uni-Knee claims did not constitute “ultimate net loss” because Stryker failed to obtain “written consent” at the time the settlements were made.

Stryker claimed that the policy, as applied to the idiosyncratic facts of this case, was latently ambiguous: because XL satisfied the Pfizer judgment first (and exhausted its policy), Stryker was forced to present its direct settlements to TIG years after they were made. Relying on the testimony of TIG’s former claims adjusters and underwriters, Stryker argued that the excess-liability policy did not actually require “consent to the Uni-Knee settlements when they were made.”

The Sixth Circuit disagreed, saying “Because Stryker did not satisfy the consent requirement, its direct settlements cannot constitute ultimate net loss, and there is no coverage under the policy.”

The emergence of a second wave of plaintiffs for hip implant cases which have already been litigated or are currently being litigated will now likely be joined by plaintiffs with injuries related to the LVIT v40 Femoral Head component recall. The recent surge in new plaintiffs for existing hip replacement litigation’s is likely due to the fact that those individuals who received their recalled or defective hip implant in the two year period prior to the problems with these devices becoming known, are just now experiencing the adverse events associated with these devices.

Urgent medical device recall

Stryker Corporation issued an urgent medical device recall on August 29, 2016 related to the Stryker LFIT Anatomic CoCr V40 Femoral Head commonly used with the Stryker Accolade Hip replacement system as well as other models and brands of hip replacement products.

The urgent medical device recall notification was related to LFIT V4o Femoral Heads manufactured prior to 2011, and therefore it is highly unlikely that any of the recalled devices would still be in the stockroom of any surgical center or other medical providers. The recall obviously affects devices that are already implanted in hip replacement patients and therefore can not simply be packaged up and sent back to the manufacturer.

Health Canada issued a similar recall several days before the voluntary recall was issued by Stryker in the United States. The notice from the Canadian Equivalent of the FDA noted that:

The taper lock is the part of the hip implant component that connects the femoral head to the femoral neck. Failure of the taper lock can result in a complete loss of movement, severe pain, instability of the entire joint,bone fracture, dislocation as well as other significant problems. Surgery will generally be required to repair any complications resulting from taper lock failure. In some cases, surgery will not repair the complication and the patient may be left permanently disabled.

Emerging LFIT V40 Litigation

The newly-released information related to the defective nature of the LFIT V40 may give rise to a large number of new hip implant lawsuits to accompany those which have already been filed over the past few years, many having been consolidated into Multidistrict Litigations (MDL) as well as State Court Litigations. A number of lawsuits which include allegations related to the LFIT V40 component have already been filed in the New Jersey Stryker Hip State Court Consolidation.

In July 2016 Annah Marie Gidora (See Gidora vs Howmedica) filed a complaint in the Southern District of New York related to the LFIT V40 Femoral Head implanted in conjunction with a Stryker Accolade. She alleges that the device is prone to fail before its expected life. As a result of the device failure Giordia alleges that she suffered a debilitating loss of mobility as well as other injuries resulting in significant pain and suffering.